Sex Differences in Opioid Use and Medical Issues During Buprenorphine/Naloxone Treatment

• Opioid use is rapidly escalating in women in the United States, making it critical to determine if opioid replacement therapy works equally as well for women as it does as men.
• Buprenorphine/naloxone is a medication used in the treatment of opioid dependence, with numerous clinical trials supporting its efficacy.
• There are sex differences in buprenorphine/naloxone clinical trials for opioid use, and studies have found that while women have fewer opioid-positive samples overall, men tend to see the greatest decrease in opioid-positive samples after treatment with buprenorphine/naloxone.

This research has largely focused on end-point analyses (statistical analyses of groups at the end of treatment), however, and many opioid use disorder pharmacotherapy trials do not make use of longitudinal data, resulting in a lack of information about sex differences in the trajectory of opioid use over the course of a clinical trial.

This study analyzed data from CTN-0003, a NIDA Clinical Trials Network study comparing buprenorphine/naloxone tapering schedules, to test for sex differences in opioid use during the trial and to determine if differences between men and women exist in the associations between addiction-related problem areas and opioid use over the course of the trial. Addiction-related problem areas were defined by Addiction Severity Index-Lite (ASI-L) domain composite scores.

The analysis revealed that women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial. For men, experiencing more medical and family problems (i.e., scoring higher in those two ASI-L domains) increased the likelihood they would test positive for opioids at the start of the trial, but no ASI-L composite scores predicted opioid use during the course of the treatment trial.

Women with higher ASI-L medical composite scores, on the other hand, demonstrated the opposite: they were less like to test positive for opioids at the start of the trial, and more likely to submit them during treatment.
Conclusions: These findings demonstrate significant sex differences in buprenorphine/naloxone treatment for opioid use disorder, with sex differences also predicting use during treatment. In addition, sex-specific risk factors such as medical problems may assist in developing more precise treatment strategies to couple with buprenorphine/naloxone therapy. Women experienced an increase in opioid use during treatment in relation to medical problems for women, suggesting that complementary treatment for medical problems during opioid replacement therapy would benefit them. Failure to address these needs may result in less successful opioid treatment for women.

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